The treatment of vascular diseases has grown exponentially in terms of sophistication and diversity. Procedures involving items such as stents or balloons are virtually routine in many health-care practices. However, despite vast advancements in many vascular procedures and medical devices, one particularly troublesome issue has remained in the field of kidney dialysis.
The number of patients requiring hemodialysis treatment grows at an alarming rate. Because patients generally require treatment until death or until kidney transplantation, the projection for the number of future hemodialysis procedures increases with each new group of patients.
Augmenting this problem is the prevalence of diabetes, which contributes directly to the number of patients requiring some form of kidney dialysis treatment. Currently, statistical data indicates that approximately twenty (20) million Americans have chronic kidney disease (CKD), while another twenty (20) million are at risk. Projections for the current population of patients with end-stage renal disease (ESRD) (which represents CKD patients requiring dialysis) are disturbing: reaching nearly 325,000 in 2002 with more than 100,000 patients beginning dialysis in 2003. Conservative estimates indicate that the prevalent rate of patients with ESRD is growing at approximately 3% per year and this rate is significantly higher in older populations (e.g. the 45-64 year range).
Concisely stated, current dialysis grafts are simply not ideal for a multitude of reasons. Many of the current shortcomings are described below in greater detail. These grafts can cause setbacks to the patient due to poor instrument design, adverse reactions from the patient's body, and higher costs for all individuals involved.
Accordingly, the ability to properly address vascular issues involving conduits within a suffering patient presents a significant challenge for device manufacturers, physicians, and surgeons alike.